Evaluation of Cerebral Elastography by Magnetic Resonance: Comparison of Healthy Subjects and Patients With Glial Tumor

NCT03274037 | Unknown

• 1 other identifier: IDRCB: 2013-A00289-36
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

MRI elastography detects the movement of tissues in the human body and monitors their response to mechanical stress in order to reveal their mechanical properties, like palpation. These depend on the structure of the tissues, their biological conditions and possible conditions. This non-invasive technique allows exploration of deep organs such as the brain that the doctor's hand can not reach. MRI elastography may prove to be an essential tool for study, diagnosis, staging and therapeutic monitoring of brain diseases. Neurodegenerative diseases (Alzheimer's, Parkinson's, Creutzfeldt-Jakobes) and cancers largely modify the mechanical properties of the affected tissues. For a first evaluation of the technique, we are interested in glial tumors representing half of the intracranial tumors in adults (incidence: 5 cases per 100 000 inhabitants), the second cancer in children and the third cause of death in l Young adult.

Conditions

Elasticity Imaging Techniques

Outcome Measures

Primary Outcomes (1)

• normal values of cerebral MRI elastography in healthy volunteers

  Mechanical excitation by pressure waves

  1 month

Secondary Outcomes (2)

• Values of shear modulus of elasticity in the brain region explored

  1 month

• Values of shear viscosity modulus according to the explored region of the brain

  1 month

Study Arms (1)

Examination of cerebral MRI elastography

EXPERIMENTAL

The mechanical waves will be induced by pressure waves guided to the mouth of the elongated subject in the MRI

Diagnostic Test: Device for mechanical excitation by pressure waves

Interventions

Device for mechanical excitation by pressure waves DIAGNOSTIC_TEST

The IRM elastography technique, proven and patented in 2010 by the IR4M (Orsay, France), consists in characterizing by IRM induced waves in the human body in order to determine the mechanical properties Of the target organ. The mechanical waves will be induced by pressure waves guided at the mouth of the subject elongated in the MRI and consisting of a function generator at a frequency between 5 Hz and 500 Hz, linear amplifier , An electromechanical transducer, a waveguide whose length is adapted to the chosen excitation frequency, an antibacterial filter and a disposable mouthpiece The MRI imager Achieva 1.5 T MRI (Philips Healthcare, Best, the Netherlands) and the SIGNA Architect GEM 3.0T (GE medical systems, LLC, USA) system will be used to measure brain tissue displacement fields.

Examination of cerebral MRI elastography

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years
• Ability to hold in an MRI device without moving
• No known and diagnosed neurological pathologies such as stroke, cerebral surgery, central nervous system tumor, inflammatory disease (such as multiple sclerosis), neurodegenerative disease (such as Alzheimer's, Parkinson's or Creutzfeldt-Jakobes's ), depression
• Informed consent
• Age between 18 and 65 years
• Ability to hold in an MRI device without moving
• Glial tumor greater than 3 mm diagnosed by standard MRI
• Informed and informed consent

You may not qualify if:

• Inability to perform an MRI examination : claustrophobia, presence of ferromagnetic metallic foreign bodies, wearing a pace-maker, metallic cardiac prosthetic valve, cochlear implants, vascular clips, insulin pump, pregnancy, breastfeeding..
• Non-affiliation to a social security scheme (beneficiary or beneficiary)
• Intercurrent disorder likely to disrupt test results
• Patient under anticoagulant:

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Denis DUCREUX

Le Kremlin-Bicêtre, France, France

RECRUITING

Study Officials

• Denis MD DUCREUX, PhD

  Assistance publique des hopitaux de paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis MD DUCREUX, PhD

CONTACT

01 45 21 33 88; denis.ducreux@bct.aphp.fr

Xavier MD MAITRE, PhD

CONTACT

01 69 15 41 34; xavier.maitre@u-psud.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: July 7, 2017
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: September 8, 2017

Record last verified: 2017-07

Locations

FR (1)